Submission of electronic adverse reaction reports from the MAH - questions and answers

Which type of adverse reaction reports can I send to the Danish Health and Medicines Authority?

Presently, the Danish Health and Medicines Authority accepts two types of electronic adverse reaction reports: ICSRs and SUSARs.

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To which ID should adverse reaction reports be submitted?

Both ICSRs and SUSARs must be submitted to DKMAEUDRA

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Are there any specific requirements for testing the transmission with the Danish Health and Medicines Authority?

You need to have a profile at the EMA.

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Who dispatches the acknowledgement (ACK), the EMA or the Danish Health and Medicines Authority? 

The Danish Health and Medicines Authority dispatches the acknowledgment (ACK).

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Do I need to notify anyone before I submit a test report?

Marketing authorisation holders must contact E2B@dkma.dk in advance of submitting a test report. We are not able to process the report before the sender ID has been configured in our system.

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Can I stop sending paper reports during the test phase?

No. During a test phase, marketing authorisation holders must continue to submit reports as usual (in paper form).

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What happens when the test phase is over?

When the test phase is over, the Danish Health and Medicines Authority sends the test results in an email to the marketing authorisation holder. If the test has returned no errors, the marketing authorisation holder can gain access to the production phase for electronic exchange of E2B files.

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When the test phase is over and the production phase starts, will there be a transtional period during which both electronic and paper reports must be submitted?

When the production phase begins, you must no longer submit paper reports.